# K973377: Sibelmed AC50D

- Pathway: 510(k) (Traditional)
- Applicant: Trutone
- Decided: Mar 10, 1998 after 183 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is an audiometer. Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

Source page: https://510kreport.com/device/K973377
Methodology: https://510kreport.com/methodology